Leaflet: information for the user

Budesonide Aldo-Union 200 micrograms/puff

Pressurized inhalation suspension

Read this leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.

1. What isBudesonide Aldo-Union 200 microgramsand what it is used for

2. What you need to know before starting to useBudesonide Aldo-Union 200 micrograms

3. How to useBudesonide Aldo-Union 200 micrograms

4. Possible side effects

5. Storage ofBudesonide Aldo-Union 200 micrograms

6. Contents of the pack and additional information

Budesonide is an effective non-halogenated corticosteroid for asthma treatment due to its anti-inflammatory properties.

It is indicated for:

- Treatment of bronchial asthma in patients who have not previously responded to bronchodilator and/or antiallergic therapy.

No useBudesonida Aldo-Unión 200 micrograms:

- If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to useBudesonida Aldo-Unión 200 micrograms.

Be especially careful with this medication:

• if you have fungal or viral respiratory tract infections or pulmonary tuberculosis.
• if you have previously been treated with oral corticosteroids: the transition from oral corticosteroid treatment to budesonide inhalation treatment should be made with special caution, mainly due to the slow normalization of the hypothalamic-pituitary-adrenal function, previously altered by oral corticosteroid therapy. This normalization may take several months to occur. During this change in medication,you may recover the original symptoms (rhinitis, eczema) or experience fatigue, headaches, muscle or joint pain, and occasionally nausea and vomiting. In these cases, symptomatic complementary treatment should be initiated.

This medication is used as maintenance treatment, it should not be used for the treatment of acute asthma attacks (sudden onset of shortness of breath and wheezing).

Do not discontinue treatment with this medication suddenly.

You should be aware of the possibility of the appearance of paradoxical bronchospasm with an increase in wheezing "pits" after administration. If the pits appear suddenly after using this medication, stop using it and consult your doctorimmediately,as you may need to change treatment.

Contact your doctor if you experience blurred vision or other visual disturbances.

Important information about one of the components ofBudesonida Aldo-Unión 200 micrograms:

It is reported to athletes that this medication contains a component that may result in a positive analytical test for doping control.

Children and Adolescents

There is another presentation, Budesonida 50 micrograms Aldo-Unión, especially indicated for children.

Other Medications andBudesonida Aldo-Unión 200 micrograms

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

Some medications may increase the effects of budesonide, so your doctor will perform thorough checks if you are taking these medications (including some for HIV: ritonavir, cobicistat).

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

This medication will only be administered during pregnancy or breastfeeding when, in the doctor's opinion, the expected benefit for the mother outweighs any possible risk to the fetus.

Driving and Operating Machines

No effects on the ability to drive and operate machines have been described.

Budesonida Aldo-Unión 200 micrograms contains ethanol:

This medication contains 0.5 mg of alcohol (ethanol) in each inhalation. The amount of alcohol in this medication is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medication does not produce any perceptible effect.

Remember to take your medication.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

This medication is administered via inhalation.

The dosage must be individualized.

Unless your doctor has given you different instructions, follow the following dosage:

Use in adults

Adults:200-1600 micrograms per day, divided into 2-4 administrations.

Use in children and adolescents

Children aged 2-7 years:200-400 micrograms per day, divided into 2-4 administrations.

Children aged 7 years and over:200-800 micrograms per day, divided into 2-4 administrations.

Once the desired clinical effects are obtained, your doctor may reduce the dose gradually to the minimum amount necessary to control symptoms.

If you estimate that the effect of this medication is too strong or too weak, inform your doctor. Do not modify your dose without first speaking with your doctor.

After using the inhaler, rinse your mouth with water. Do not swallow. This will make it less likely for adverse effects to occur in the mouth or throat.

Instructions for correct administration of the preparation:

Before using the medication, check the expiration date.

1. Remove the cap (fig.1). In case of a new inhaler or one that has not been used for several days, shake the aerosol (fig. 2) and perform a pulse to ensure the good functioning of the inhaler. In case of regular use, proceed to the following instructions:
2. Shake the inhaler (fig. 2).
3. Exhale as much air as possible from your lungs.
4. Attach the aerosol to your mouth as indicated in the drawing (fig. 3).
5. Breathe in as deeply as possible.

You must press, according to the arrows in the drawing (fig. 4), the device while making this inspiration.

1. Remove the aerosol from your mouth and try to hold your breath for a few seconds.
2. You should periodically clean the mouthpiece-adaptor of the aerosol. To do this, remove the mouthpiece from the aerosol and clean it with a cloth or a paper towel.
3. Store with the cap in place and to protect it from dust and dirt.

Your doctor should check that you know how to use the inhaler and synchronize the inspiration with the pulse.Optional cameras can be used to achieve better dose utilization and facilitate the arrival of the medication to the lungs.

The inhaler has a dose indicator that can be seen through a small hole or window of the mouthpiece and indicates how many applications are left. In a new inhaler, you can read through the window of the mouthpiece "120" or "200" (depending on the size of the package that has been prescribed to you). These numbers correspond to the doses left in the inhaler. As you use the inhaler, the dose indicator will rotate in a decreasing manner every 5-7 pulses until it reaches 0.

When there are approximately 40 doses left, the indicator changes from green to red (see figure 5) to remind the patient to consult their doctor if they need to continue treatment or if they need a new prescription. Discard the inhaler once the indicator reaches "0".

(figure 5)

If you use moreBudesonida Aldo-Unión 200 microgramsthan you should

It is essential that you take your dose as indicated by your doctor. Do not increase or decrease your dose without medical supervision.

Although no toxic symptoms are expected from overdose or accidental ingestion, if you have inhaled more budesonida than you should, consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, contact the Toxicological Information Service. Phone 91 562 04 20.

If, in any special circumstance, you observe symptoms of edema, swelling of the face or full moon face, etc., you should inform your doctor so that the necessary measures can be taken.

If you forgot to use Budesonida Aldo-Unión 200 micrograms

Do not use a double dose to compensate for the missed doses.

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

Occasionally, cases of mild throat irritation, cough, and hoarseness have been described. In addition, cases of Candida overinfection in the oral, pharyngeal, and laryngeal cavities have been reported. In most cases, it responds to topical antifungal therapy, without the need to interrupt budesonide treatment. In exceptional cases, skin allergic reactions (urticaria, dermatitis) associated with the use of topical corticosteroids have been described.

You should be aware of the possibility of paradoxical bronchospasm with an increase in "whistling" sounds after administration. If the whistling sounds appear suddenly after using this medication, stop using it and consult with your doctorimmediately,as you may need to change treatment.

Unknown frequency (cannot be estimated from available data):

Sleep disturbances, depression or feeling of concern, restlessness, nervousness, excitability, or irritability (these effects are more likely to occur in children), and blurred vision (see also section 2:Warnings and Precautions).

If you experience adverse effects, consult your doctor or pharmacist or nurse, even if they do not appear in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Store below30°C. Protect from direct sunlight and do not freeze or refrigerate.

The container contains a pressurized liquid. Do not expose to temperatures above 50°C. Do not puncture the container even if it appears empty.

Do not use this medication after the expiration date that appears on the packaging after CAD:. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofBudesonide Aldo-Unión 200 micrograms.

- The active ingredient is budesonide.

- The other components (excipients) are oleic acid, ethanol, and Norflurano.

Appearance of the product and contents of the packaging

Budesonide Aldo-Unión 200 micrograms is presented in the form of an inhalation suspension in a pressure container with a dose indicator in a 6 ml format container that allows for 120 applications and a 10 ml format container that allows for 200 applications.

Holder of the marketing authorization and responsible for manufacturing

Laboratorio Aldo-Unión, S.L.

Baronesa de Maldá, 73

08950 Esplugues de Llobregat (Barcelona)

Spain

Date of the last review of this leaflet:March 2023

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es.